MedTech Dive March 7, 2024
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.
The Food and Drug Administration cleared the first over-the-counter continuous glucose monitor (CGM) on Wednesday, allowing people to buy a new sensor made by Dexcom without a prescription. Dexcom had initially sought to offer its new Stelo device to people with Type 2 diabetes who don’t take insulin, but the FDA expanded on that, opening the CGM to most adults who don’t take insulin.
The broad indication clears a pathway for Dexcom to grow its CGM business, and for rival Abbott, which plans to bring a wellness-focused sensor to the U.S.
“The indication for use is broad,”...
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